Manufacturing

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Articles

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

Primary Packaging for Combination Products

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval. 

Mayne Enters 20-Year Agreement with Mithra for Oral Contraceptive Commercialization

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

Hovione Technology Develops Blister-Based Inhaler

Mark Gordon is product manager at Trelleborg Sealing Solutions Healthcare and Medical

Andrew Gaillard is global director at Trelleborg Sealing Solutions Healthcare and Medical. 

API can be mixed with silicone and other polymers to create drug-delivery combination products. 

Designing Combination Products

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York. 

Aptar Adds Nasal Pump Manufacturing Capacity

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Combination Products Raise New Manufacturing Challenges

Shana K. Cyr is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Paula Miller is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Deborah M. Herzfeld is an attorney at McNeill Baur PLLC.

Robert F. Shaffer is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

The authors discuss regulatory and patent issues with combination products.

Combination Products: Regulatory and Patent Issues You Should Consider Now

PMMI, The Association for Packaging and Processing Technologies, released a report on trends opportunities in packaging of pharmaceuticals and medical devices that predicts increased spending on capital equipment for processing and packaging.

Packaging Association Releases Pharma Packaging Market Report

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Mylan CEO Heather Bresch appeared before the House Committee on Oversight and Government Reform on Sept. 21, 2016 to explain the company’s decision to increase the price of EpiPen more than 400%. The meeting comes after multiple members of Congress raised concerns about the price of the life-saving drug, which is used to treat anaphylaxis.

Manufacturing, Combination Drugs